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| Name | Class |
|---|---|
| Aga Khan Health Services | OTHER |
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A double-blind individual randomized controlled study of misoprostol vs. placebo for treatment in homebirths in the Chitral district, in the Khyber Pakhtunkhwa province in Pakistan.
A double-blind individual randomized controlled study of misoprostol vs. placebo for treatment in homebirths in the Chitral district, in the Khyber Pakhtunkhwa province in Pakistan. The purpose of the study is to assess the overall clinical and programmatic effectiveness of Traditional Birth Attendants (TBAs) administering 800 mcg sublingual misoprostol to treat Postpartum Haemorrhage (PPH) at the community level.
The study will recruit pregnant women who deliver at home. All women enrolled in the study will receive misoprostol for prevention (600 mcg oral dose). Women diagnosed with PPH will be randomized to receive either a) standard care + 800 mcg sublingual misoprostol (four 200 mcg tablets) or b) standard care + four placebo tablets resembling misoprostol. In this setting, standard care is uterine massage and/or compression and referral to the nearest health facility or attendance by the Lady Health Visitor/ Community Health Nurse.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Misoprostol | Active Comparator | women who experience a PPH will be randomized to receive 800 misoprostol (four tablets of 200 mcg administered sublingually) |
|
| placebo | Placebo Comparator | women who experience a PPH will be randomized to receive 4 placebo tablets administered sublingually |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Misoprostol | Drug | 4 tablets of 200 mcg misoprostol administered sublingually if the woman experiences a PPH after child birth |
|
| Measure | Description | Time Frame |
|---|---|---|
| Haemoglobin concentration (Hb) of greater than or equal to 2 g/dl from pre- to post-delivery | The primary outcome will measure the proportion of women who experience a drop in their haemoglobin concentration (Hb) of greater than 2 g/dl from pre- to post-delivery. | 3-5 days after delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants who experience side effects | number of women who experienced side effects and the severity of the side effects as rated on a scale, additional care provided | immediately after delivery; 3-5 days post delivery |
| number of participants who received additional interventions |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zafar Khan | Aga Khan Health Services | Principal Investigator |
| Nadeem Zuberi | Aga Khan University | Study Director |
| Gijs Walraven | Secretariat of His Highness the Aga Khan, Aiglemont | Study Director |
| Ayisha Diop | Gynuity Health Projects | Study Director |
| Dina Abbas | Gynuity Health Projects | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Home Births | Chitral | Khyber Pakhtunkhwa | Pakistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33232518 | Derived | Parry Smith WR, Papadopoulou A, Thomas E, Tobias A, Price MJ, Meher S, Alfirevic Z, Weeks AD, Hofmeyr GJ, Gulmezoglu AM, Widmer M, Oladapo OT, Vogel JP, Althabe F, Coomarasamy A, Gallos ID. Uterotonic agents for first-line treatment of postpartum haemorrhage: a network meta-analysis. Cochrane Database Syst Rev. 2020 Nov 24;11(11):CD012754. doi: 10.1002/14651858.CD012754.pub2. | |
| 30582753 |
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| ID | Term |
|---|---|
| D006473 | Postpartum Hemorrhage |
| ID | Term |
|---|---|
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D016595 | Misoprostol |
| ID | Term |
|---|---|
| D011459 | Prostaglandins E, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
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| placebo | Other | 4 tablets, administered sublingually if the woman experiences a PPH |
|
|
number of participants who received care by as skilled provider and the type of care provided |
| immediately after delivery; 3-5 days post delivery |
| number of women who found misoprostol treatment to be acceptable | women will be asked to rate their acceptability with the treatment using a scale | immediately after delivery; 3-5 days post delivery |
| number of participants who experience severe adverse events | serious adverse are defined as uterine rupture, hysterectomy, hospitalization, maternal deaths, and neonatal deaths. | immediately after delivery; 3-5 days post delivery |
| Derived |
| Abbas DF, Jehan N, Diop A, Durocher J, Byrne ME, Zuberi N, Ahmed Z, Walraven G, Winikoff B. Using misoprostol to treat postpartum hemorrhage in home deliveries attended by traditional birth attendants. Int J Gynaecol Obstet. 2019 Mar;144(3):290-296. doi: 10.1002/ijgo.12756. Epub 2019 Jan 24. |
| D011644 | Puerperal Disorders |
| D014592 | Uterine Hemorrhage |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005231 |
| Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |